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Vasco® Nitril cloud-white

Vasco® Nitril cloud-white

Vasco® Nitril cloud-white

Product catalog summary
Overview: The document is a technical data sheet for Vasco® Nitril cloud-white non-sterile examination and protective gloves, produced by B. Braun Avitum AG. It outlines compliance with various standards, technical specifications, and performance data.
Compliance and Standards: The gloves are classified as Medical Device Class I under the Medical Device Regulation (EU) 2017/745 and as Personal Protective Equipment (PPE) Category III under PPE Regulation (EU) 2016/425. They comply with standards EN 455 1-4, EN ISO 21420, EN ISO 374, EN 16523, and ISO 16604. Quality certifications include ISO 9001 and ISO 13485.
Technical Specifications: The gloves are made from nitrile butadiene rubber (NBR), free of latex proteins, and contain accelerators like Zn-dibutyldithiocarbamate (ZDBC). They are ambidextrous with a rolled rim cuff and textured fingertips. The gloves are available in sizes XS to XL, with specific dimensions for palm width and total length. Physical properties include a wall thickness of 0.05-0.08 mm, force at break of 6 N, and tensile strength of 14 MPa.
Performance and Testing: The gloves have been tested for chemical resistance, showing varying levels of permeation and degradation against chemicals like sodium hydroxide, hydrogen peroxide, and formaldehyde. They also demonstrate resistance to bacteria, fungi, and viruses. For cytostatic drugs, the gloves are tested for permeation breakthrough times, indicating suitability for prolonged use with most drugs.
Logistics and Storage: The gloves are packaged in dispenser packs of 150/135 pieces, with a shelf life of 5 years. They should be stored at temperatures between 5°C and 38°C, away from sunlight, ozone, dust, and humidity.
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Catalog excerpts

Vasco® Nitril cloud-white -1

Vasco® Nitril cloud-white NON STERILE EXAMINATION AND PROTECTIVE GLOVES | DATA SHEET B. Braun Avitum AG confirms that Vasco® Nitril cloud-white gloves comply with the following standards and regulations: EC CERTIFICATES AND APPLIED STANDARDS Medical Device Class I according to Medical Device Regulation (EU) 2017/745 EN 455 1-4 Personal Protective Equipment Category III according to Personal Protective Equipment Regulation (EU) 2016/425 EN ISO 21420, EN ISO 374, EN 16523, ISO 16604 QUALITY CERTIFICATES PERSONAL PROTECTIVE EQUIPMENT Information and Declaration of Conformity according to PPER (EU) 2016/425: www.bbraun.com/gloves-declarations-of-conformity http://www.intcomedical.com/download.html Anhui Intco Medical Products Co., Ltd No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County Huaibei City, Anhui Province, China B. Braun Avitum AG Schwarzenberger Weg 73 - 79 34212 Melsungen Germany B. Braun Avitum AG | www.bbraun.com | Doc. TD_VascoNitril_cloud-white | page 1 of 6   08/2

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Vasco® Nitril cloud-white -2

Vasco® Nitril cloud-white NON STERILE EXAMINATION AND PROTECTIVE GLOVES | REGULATORY INFORMATION MEDICAL DEVICE INFORMATION FOOD COMPLIANCE Conformity for food contact according to 1935/2004/EEC PERSONAL PROTECTIVE EQUIPMENT INFORMATION Tested in accordance with: EN ISO 374-1:2016 +A1:2018/Type B Code letter Test chemical Performance levels acc. EN ISO 374-1:2016 +A1:2018 Measured breakthrough times (mins) Degradation levels indicate the change in puncture resistance of the gloves after exposure to the challenge chemical. NOTE: Where the test specimens gave an increased puncture force after chemical...

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Vasco® Nitril cloud-white -3

Vasco® Nitril cloud-white NON STERILE EXAMINATION AND PROTECTIVE GLOVES | TECHNICAL DATA PHYSICAL PROPERTIES Wall thickness GLOVE DESIGN GLOVE MATERIAL Typical value During shelf life 6 N Before ageing After ageing Before ageing After ageing straight fingers, ambidextrous fitting rolled rim, regular cuff Surface finish fingertip textured Inner glove surface polymer coated, powder-free Nitrile butadiene rubber (NBR) Latex allergy risk Tensile strength Total length free of latex proteins Zn-dibutyldithiocarbamate (ZDBC) Free of thiurames and mercaptobenzothiazoles MBT LOGISTIC INFORMATION Dispenser...

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Vasco® Nitril cloud-white -4

SHARING EXPERTISE Tested by ProQuares, NL, or SATRA Technology Europe Limited, Rep. of Ireland (NB2777) EN 16523-1: Determination of material resistance to permeation by chemicals. CHEMICAL CAS PERMEATION BREAKTHROUGH REGISTRATION NO. PERFORMANCE LEVEL TIME Benzalkonium Chloride 50 % 63449-41-2 level 6 > 480 min Chlorhexidine gluconate 4 % 18472-51-0 level 6 > 480 min Hydrochloric acid 37 % 7647-01-0 level 3 > 60 min Hydrogen peroxid 30 % 7722-84-1 level 2 > 30 min Isopropyl Alcohol, 99 % 67-63-0 level 1 > 10 min Silver Nitrate 0.5 % 7761-88-8 level 6 > 480 min Sodium hydroxide 40 % 1310-73-2...

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Vasco® Nitril cloud-white -5

SHARING EXPERTISE Vasco® Nitril cloud-whiteNON STERILE EXAMINATION AND PROTECTIVE GLOVES | BARRIER PROPERTIES - CYTOSTATIC DRUGS Tested by ARDL, USA, or Proquares, NL in accordance with ASTM D 6978: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum detection rate 0,01 |ag/cm2/min CAS REGISTRY NO. MIN BREAKTHROUGH DETECTION TIME Suitable if changed before permeation breakthrough n Suitable for prolonged use Arsenic Trioxide Bleomycin sulfate Bortezomib (Velcade) Cetuximab (Erbitux) B. Braun Avitum AG | www.bbraun.com | Doc. TD_VascoNitril_cloud-white...

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Vasco® Nitril cloud-white -6

SHARING EXPERTISE Vasco® Nitril cloud-whiteNON STERILE EXAMINATION AND PROTECTIVE GLOVES | BARRIER PROPERTIES - CYTOSTATIC DRUGS Tested by ARDL, USA, or Proquares, NL in accordance with ASTM D 6978: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum detection rate 0,01 |ag/cm2/min CAS REGISTRY NO. MIN BREAKTHROUGH DETECTION TIME Suitable if changed before permeation breakthrough n Suitable for prolonged use Vincristine Sulfate Zoledronic Acid B. Braun Avitum AG | www.bbraun.com | Doc. TD_VascoNitril_cloud-white | page 6 of 6 08/2023

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